FDA Adverse Event
Malfunction
Summary report: N
DISPOSABLE FALOPE-RING BAND APPLICATION KIT
MDR report key: 1406067
·
Received June 18, 2009
Report
- Report Number
- 2183680-2009-00059
- Event Type
- Malfunction
- Date Received
- June 18, 2009
- Date of Event
- February 25, 2009
- Report Date
- June 18, 2009
- Manufacturer
- GYRUS MEDICAL INC.,
- Product Code
- KNH
- PMA / PMN Number
- P870076
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL. GYRUS ACMI WAS TOLD THAT THE DEVICE IS BEING HELD BY THE FACILITY'S RISK MANAGEMENT DEPARTMENT AND WILL NOT BE RETURNED FOR EVAL AS THE FACILITY DOES NOT RELEASE DEVICES THAT HAVE FAILED. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.
Description of Event or Problem · 1
INFO REGARDING THIS COMPLAINT WAS SENT TO US VIA THE FDA'S REPORT (B) (4). ADVOCATE (B) (6) HOSPITAL NEVER INFORMED GYRUS ACMI, INC. OF THE MALFUNCTION OF OUR DEVICE, (B) (4), DURING A PROCEDURE. THE DISPOSABLE FALOPE-RING BAND MISFIRED DURING A TUBAL LIGATION PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISPOSABLE FALOPE-RING BAND APPLICATION KIT | DISPOSABLE FALOPE-RING BAND APP KIT | KNH | GYRUS MEDICAL INC., | 006889-901 | 8273103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |